Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter

Phase 2

Completed

Conditions: Benign Prostatic Hyperplasia
Benign Prostatic Hypertrophy

Interventions: Device: Optilume™ BPH Prostatic DCB Dilation Catheter
Drug: Paclitaxel

Registration Number: NCT03423979

Lead Sponsor: Urotronic Inc.

Brief Summary: A prospective, non-randomized study. The subjects will be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. The post-treatment follow-up visit can be up to 5 years.

The objective of the study is to evaluate the safety and efficacy of the Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System in the treatment of BPH.

Detailed Description: A prospective, non-randomized, multi-center study. The study will enroll up to 85 subjects to be enrolled and treated with the Optilume BPH Prostatic DCB Dilation Catheter System at up to 8 clinical sites. Subjects will be followed up post-treatment at Foley removal, and up to 1 year. The subjects may choose to be followed-up annually for 5 years or until study close, whichever comes first.

Study device is Optilume™ BPH Prostatic Drug Coated Balloon Dilation Catheter System.

Study primarily outcomes are measured by 1). Change in IPSS score at 3-month post-procedure follow-up; 2). Major device or procedure related complications at 3-month post-procedure follow-up.

Recruitment & Eligibility

Status: COMPLETED

Sex: Male

Target Recruitment: 80

Inclusion Criteria

Male subject > 50 years of age who has moderate-to-severe LUTS (IPSS score of ≥ 13) and is a candidate for interventional therapy
LUTS felt to be secondary to an enlarged prostate (henceforth termed LUTS/BPH)
Peak urinary flow rate (Qmax) ≥ 5 mL/sec and ≤ 15 ml/sec with minimum voided volume of ≥ 125 ml
Post-void residual (PVR) ≤ 250 ml
Prostate volume 20 - 80 gm as determined by TRUS
Prostatic urethra length is 35 - 55 mm as determined by TRUS
Able to complete the study protocol in the opinion of the investigator

Exclusion Criteria

Interested in maintaining fertility and unwilling to use protected sex for the first 30 days post treatment
Unwilling to abstain or use protected sex for ninety (90) days post treatment if sexual partner is of child bearing potential
Presence of a penile implant or stent(s) in the urethra or prostate
Any prior minimally invasive intervention (e.g. TUNA, Balloon, Microwave, Rezūm, UroLift) or surgical intervention of the prostate
PSA > 10 ng/ml unless prostate cancer is ruled out by biopsy. If PSA is > 4 ng/ml and ≤ 10 ng/ml, prostate cancer must be ruled out to the satisfaction of the investigator via additional tests including digital rectal exam (DRE) and/or biopsy
Confirmed or suspected malignancy of prostate or bladder
Active or history of epididymitis within the past 3 months
Previous pelvic irradiation or radical pelvic surgery
Documented active urinary tract infection (UTI) by culture or bacterial prostatitis within last year documented by culture (UTI is defined as >100,000 colonies per ml urine from midstream clean catch or catheterization specimen)
Visible hematuria with subject urine sample without known contributing factor
Neurogenic bladder or sphincter abnormalities or neurological disorders that might affect bladder or sphincter function
Previous or current diagnosis of urethral strictures, bladder neck contracture or detrusor muscle spasms
Use of beta blockers, antihistamines, anticonvulsants, or antispasmodics within 1 week prior to treatment unless there is documented evidence of stable dosing for last 6 months (no dose changes)
Use of alpha blockers, antidepressants, anticholinergics, androgens, daily tadalafil or gonadotropin-releasing hormonal analogs (prescribed for BPH) within 3 weeks prior to treatment
Use of 5-alpha reductase inhibitor within 6 months prior to treatment
Incidence of spontaneous urinary retention within 6 months prior to baseline assessment
Post-void residual volume > 250 ml or catheter dependent bladder drainage
Overactive bladder (OAB) or urge incontinence
Known poor detrusor muscle function (e.g. Qmax < 5 ml/sec)
Current bladder stones or prostatic calculi
Biopsy of prostate within 30 days prior to procedure or planned within 30 days following the procedure
History of cancer in non-genitourinary system which is not considered cured (except basal cell or squamous cell carcinoma of the skin). A potential participant is considered cured if there has been no evidence of cancer within five years
History of clinically significant comorbidities or presence of unstable conditions (e.g. cardiovascular, lung, renal [serum creatinine > 2.0 mg/dl], hepatic, bleeding disorders, or metabolic impairment) that may confound the results of the study or have a risk to subject per investigator's opinion
Any cognitive disorder that interferes with or precludes direct and accurate communication with the study investigator regarding the study or affects the ability to complete the study quality of life questionnaires
Expected life expectancy < one year
Unable or unwilling to sign the Informed Consent Form (ICF) and/or comply with all the follow-up requirements
Currently enrolled in or plan to enroll in another investigational clinical trial for any disease except for observational only study
In the opinion of the investigator, it is not in the subject's best interest to participate in the study
Current treatment with anti-coagulants (e.g., warfarin or enoxaparin) or anti-platelet medications other than aspirin (e.g., clopidogrel)
Anatomy, e.g. presence of false passage or size of meatus, is not suitable for treatment in this study
Device that corresponds with the subject's prostate size per the IFU is not available
Intravesical prostatic protrusion (IPP) > 1 cm
Current uncontrolled diabetes (hemoglobin A1c > 7%)
Unable or unwilling to provide all the protocol-required semen samples
Sensitivity to paclitaxel, on medication that may have negative interaction with paclitaxel, or contraindicated for systemic paclitaxel

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Optilume™ BPH Prostatic DCB Dilation Catheter	Optilume™ BPH Prostatic DCB Dilation Catheter	Optilume™ BPH Prostatic DCB treatment procedure
Optilume™ BPH Prostatic DCB Dilation Catheter	Paclitaxel	Optilume™ BPH Prostatic DCB treatment procedure

Primary Outcome Measures

Name	Time	Method
Therapeutic Responder at 3 Months	90 days	The proportion of subjects experiencing at least a 40% improvement in International Prostate Symptom Score (IPSS) scores from baseline to 3 months. The IPSS contains the well-validated, highly reliable and responsive American Urological Association symptom score (AUASS) assessment to identify the severity of BPH symptoms. The first seven questions in the IPSS address frequency, nocturia, weak urinary stream, hesitancy, intermittence, incomplete emptying, and urgency, and scored on a 6-point scale (0 to 5). The IPSS can be interpreted as follows: 0-7 mildly symptomatic, 8-19 moderately symptomatic, and 20-35 severely symptomatic.
Major Device/Procedure Related Complications	90 days	The proportion of subjects reporting a composite of device/procedure related severe urinary retention (lasting \>14 days), unresolved stress urinary incontinence, or bleeding requiring transfusion.

Secondary Outcome Measures

Name	Time	Method

Trial Locations

Locations (5): Urolaser SRL
🇩🇴
Santo Domingo Oeste, Santo Domingo, Dominican Republic
Centro Especializado San Fernando
🇵🇦
Ciudad de Panamá, Panama
Centro Medico Dr. Canela, SRL
🇩🇴
La Romana, Dominican Republic
Union Medica Hospital
🇩🇴
Santiago De Los Caballeros, Santiago, Dominican Republic
Consultorios Royal Center
🇵🇦
Panama City,, Urbanización Marbella Ciudad De Panamá, Panama